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510(k) Data Aggregation
(371 days)
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The Access® Toxo IgM assay is a paramagnetic-particle chemiluminescent immunoassay for the qualitative detection of anti-Toxoplasma IgM in adult human serum, using the Access® Immunoassay System. The Access® Toxo IgM assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or nonpregnant females. It is recommended this assay be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The acceptance criteria for the Beckman Instruments ACCESS® Toxo IgM assay and its reported performance are described below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity (vs. predicate) | Not explicitly stated as a numerical criterion, but the context implies substantial equivalence to the predicate device, Platelia® Toxo IgM. | 96% |
| Specificity (vs. predicate) | Not explicitly stated as a numerical criterion, but the context implies substantial equivalence to the predicate device, Platelia® Toxo IgM. | 99.7% |
| Resolved Sensitivity | Not explicitly stated as a numerical criterion. | 96% (after discrepancy analysis) |
| Resolved Specificity | Not explicitly stated as a numerical criterion. | 99.7% (after discrepancy analysis) |
| Specificity (in prospective population with 1.25% prevalence) | Not explicitly stated as a numerical criterion, but relative to a consensus result in a specific population type. | 99.2% |
| Intra-assay Precision (CV) | Not explicitly stated as a numerical criterion, but typically |
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